Report from the CMDh meeting held on September !!! 3 months to go until the mandatory use of the electronic application form!!!

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1 Report from the meeting held on September 2015!!! 3 months to go until the mandatory use of the electronic application form!!! Pharmacovigilance positions following PSUSA procedure for only nationally authorised products The, having considered the PSURs on the basis of the PRAC recommendations and the PRAC assessment reports, agreed by consensus on the variations of the marketing authorisations of medicinal products containing the following active substances: Altizide, spironolactone Cyproheptadine Delapril Furosemide Hydrochlorothiazide, spironolactone Lormetazepam Methylprednisolone Phenylephrine Tizanidine Valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium 5 fluorouracil (topical application) Further information regarding the above-mentioned PSUSA procedures, including information on the implementation, will be published on the EMA website WC0b01ac b8d Outcomes of informal PSUR work-sharing procedures The has adopted the conclusions of PSUR assessments for acipimox, atovaquone, azitromycin, ciprofloxacin, finasteride, oxcarbazepine and ropivacaine, which may require changes to the product information or introduction of other risk minimisation measures. The public summaries will be published on the website under Pharmacovigilance, PSURs, Outcome of informal PSUR work-sharing procedures. MAHs of the products concerned should implement the outcome of the assessment by the appropriate variation or other procedure (as advised) within 90 days of publication. NEW- Request form for MRP/Repeat-use procedures The has agreed to introduce a Request Form for MRP/RUP procedures available for the National Competent Authorities (NCA). The request form will be published on the website for transparency, together with a cover note explaining that due to different organisations and thereby also different working procedures for the approved medicinal products in member states, the Request Form may need to be adapted at national level and is not mandatory for the NCAs to use. Marketing authorisation holders should approach the reference member state to discuss the update of the AR in the MRP/RUP as appropriate and use the request form available from the RMS, if applicable. Date of publication: 29 September 2015 Page 1/7

2 The Request Form will be revisited after a pilot period of maximum 1 year. The request form will be published together with an appendix for approved variations/renewal(s)/ commitments submitted subsequent to the finalisation of the European/National assessment/the issued marketing authorisation and a template for the update assessment report for MRP/RUP overview of procedures. The documents will be published under Procedural Guidance, Application for MA, MRP and Templates, respectively. The also agreed to allow administrative renewals and variations to change the QPPV in parallel to MRP/repeat-use procedures. Updates of the list of safety concerns per approved Risk Management Plan (RMP) of active substances per product Following the publication of the list of safety concerns per approved Risk Management Plans (RMPs) of active substances per product in April, the agreed to update the related cover note to provide guidance for Member States and MAHs on how to submit information for updates of the list. Templates for providing the information will also be made available. The updated cover note together with the templates will be published under Pharmacovigilance, RMP. Strategy to 2020 For public consultation The has worked on a document to outline the key priorities for the and a high level strategy to achieve these. The document has been developed in parallel and is complementary to the HMA/EMA common network strategy paper 2020 and will be complemented by work plans. The main focus of the strategy is on role in the network Improvement of MRP/DCP Post-marketing Legislation Telematics Communication The draft document will be published for 2 months of public consultation. Comments should be sent to the Secretariat by 30 November 2015, coordinated by trade associations where possible. The document will be published under About, Activities. EU Work-sharing Articles 45 of the Paediatric Regulation Public Assessment Reports The has agreed on public assessment reports for paediatric studies submitted in accordance with Article 45 of the Paediatric Regulation for amitriptyline and epinephrine including recommendations for the text to be included in SmPCs and package leaflets. The further agreed on an update of the public assessment report for budesonide. The public assessment reports will be published on the website, under Paediatric Regulation, Assessment reports. Marketing Authorisation Holders of medicinal products with same active substances and pharmaceutical forms are requested to include this information in their SmPCs and package leaflets within 90 days of publication of the public assessment reports, in accordance with the Best Practice Guide Article 45, EU worksharing procedure. Page 2/7

3 /EMA Working Party on Paediatric Regulation The has agreed a list of active substances for wave 28 of the worksharing for the assessment of paediatric studies submitted in accordance with Article 45 of the Paediatric Regulation. Marketing Authorisation Holders will be requested to submit the paediatric studies to the appointed Rapporteur within one month of the request (i.e. by mid of November 2015). The list of active substances included in the wave 28 of the Article 45 work-sharing procedure will be published on the website. Variation Regulation (EC) No 1234/2008 The has agreed an updated version of the Questions & Answers on variations. Question 4.16 has been amended to clarify the scope of the answer. The amended document will be published on the website under Questions and Answers. Revision of the Best Practice Guide on the compilation of the dossier for new applications submitted in MRP/DCP The has adopted a new version of its BPG on compilation of the dossier for new MRP/DCP applications. The document was amended to align the information on the change of the future MAH to other guidance documents. The adopted document will be published under Procedural Guidance, Application for MA. Revision of Data requested for Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers The has adopted an updated version of the document Data requested for Applications in the MRP/DCP. The updated document will be published under Procedural Guidance, Application for MA. Revision of compilation on Mock-ups, Specimens and Samples for new applications The has adopted an updated version of the document Mock-ups, Specimens and Samples for new applications. The updated document will be published under Procedural Guidance, Application for MA. Timetables for requests for recommendations on the classification of an unforeseen variation in accordance with Article 5 of Regulation (EC) No. 1234/2008 The has adopted an updated guidance document with the timetables for requests for recommendations on the classification of unforeseen variations in The updated guidance document will be published on the website under Procedural guidance, Variation, Art. 5 recommendations. Timetables for MRP/DCP applications referred to the in accordance with Article 29(1) of Directive 2001/83/EC The has adopted an updated guidance document with the timetables for MRP/DCP applications referred to the for the 60-days referral procedure in The updated guidance document will be published on the website under referrals. Recommendations on submission dates for Applicants of the MRP and DCP The has adopted updated guidance documents with the timetables for MRP/DCP applications to be submitted in The updated guidance documents will be published on the website under Procedural guidance, Application for MA, MRP/DCP. Page 3/7

4 Implementation of Commission Decisions after Article 30 referral procedures A link to the Commission decisions, including SmPC, package leaflet and labelling, on the Article 30 referral procedures for Amoxil and associated names will be published on the website. Generic Companies are encouraged to contact the Reference Member State to harmonise the product information of the medicinal products authorised via MRP/DCP to conform to the Commission Decision, through submission of a type IB variation under classification C.I.1.b, provided the conditions set up in Regulation (EC) No 1234/2008 are met. The will update the tracking table on referrals in accordance with Article 30 of Directive 2001/83/EC to include MRP procedure numbers following the referral procedures, once known. The updated tracking table will be published on the website. NEW APPLICATIONS Mutual Recognition Procedure The noted that 32 Mutual Recognition Procedures were during the months of July and August No Mutual Recognition Procedure was referred to in this period. 2 Mutual Recognition Procedures were referred to CHMP in this period. The status as of 31 st August 2015 of procedures under Mutual Recognition is as follows: Year applications 1 applications in process Referred to Agreement reached in the Withdrawn during referral Applications referred to CHMP referred to in Mutual Recognition Procedures (regarding 80 products) started in July and August The categories of these procedures are as follows: - 35 abridged applications (including 21 repeat use procedures and 8 multiple applications); - 17 known active substance applications (including 9 repeat use procedures); - 1 new active substance applications (initial application). The new procedures started in July and August 2015 related to the following applications: 3 full dossier, 38 generic, 9 well-established use and 3 hybrid applications. 50 of these procedures consisted of chemical, 1 procedure of biological (blood product), 1 procedure of biological (others) and 1 herbal product. 49 of these procedures related to prescription-only medicinal products and 4 procedures related to nonprescription medicinal products in the reference Member State 2. 1 Due to late database updates cumulative yearly figure differs from the monthly figures. Cumulative yearly figure includes late database updates on procedures not captured in the monthly figures published in press releases. The applications referred to CHMP are included in the new applications. 2 In this category products are classified as prescription-only or Non-prescription (OTC) products as applied for in the RMS, although the legal status is not part of the Decentralised Procedure. Page 4/7

5 applications in Mutual Recognition procedure started in July and August 2015: Member State Number of times involved in a Number of times involved in a procedure as RMS procedure as CMS Austria 3 6 Belgium 1 13 Bulgaria 7 Croatia 8 Cyprus 2 Czech Republic 10 Denmark 21 6 Estonia 7 Finland 7 France 13 Germany 7 22 Greece 6 Hungary 2 6 Iceland 10 Ireland 7 Italy 15 Latvia 6 Liechtenstein Lithuania 7 Luxembourg 10 Malta 3 Netherlands 8 12 Norway 9 Poland 12 Portugal 2 8 Romania 7 Slovak Republic 1 6 Slovenia 5 Spain 9 Sweden 5 15 United Kingdom 3 14 Decentralised Procedure The noted that 197 Decentralised procedures with positive outcome and 2 procedures with negative outcome were during July and August Decentralised procedures were withdrawn after day 120 in this period. 4 Decentralised Procedures were referred to the in this period. No Decentralised Procedure was referred to the CHMP in this period. The status as of 31 st August 2015 of procedures under Decentralised Procedure is as follows: Year applications 3 applications withdrawn 3 (After day 120) applications in process Referred to Agreement reached in the Withdrawn during referral Referred to CHMP referred to in Due to late database updates cumulative yearly figure differs from the monthly figures. Cumulative yearly figure includes late database updates on procedures not captured in the monthly figures published in press releases. For procedures, this cumulative figure includes positive and negative procedures as well as those referred to CHMP. Page 5/7

6 201 Decentralised Procedures (regarding 420 products) started in July and August The categories of these procedures are as follows: abridged applications (including 5 multiple applications); - 48 known active substance applications (including 1 multiple application); - 2 extension applications. The Decentralised Procedures started in July and August 2015 related to the following applications: 6 full dossier, 142 generic, 23 well-established use, 24 hybrid, 3 fixed combination, 2 herbal traditional use and 1 similar biological application. 197 of these procedures consisted of chemical substances, 2 procedures of biological (others) and 2 procedures consisted of herbal products. 180 of these procedures related to prescription-only medicinal products and 21 procedures related to nonprescription medicinal products in the reference Member State 4. applications in Decentralised procedure started in July and August 2015: Member State Number of times involved in a Number of times involved in a procedure as RMS procedure as CMS Austria 5 32 Belgium 4 27 Bulgaria 19 Croatia 1 10 Cyprus 15 Czech Republic 3 36 Denmark Estonia 2 11 Finland 4 29 France 1 32 Germany Greece 23 Hungary 2 26 Iceland 4 Ireland 3 16 Italy 40 Latvia 1 12 Liechtenstein Lithuania 15 Luxembourg 31 Malta 4 13 Netherlands Norway 25 Poland 5 53 Portugal Romania 23 Slovak Republic 1 25 Slovenia 12 Spain Sweden United Kingdom In this category products are classified as prescription-only or Non-prescription (OTC) products as applied for in the RMS, although the legal status is not part of the Decentralised Procedure. Page 6/7

7 VARIATIONS AND RENEWALS Mutual Recognition and Decentralised Procedures The noted that 661 type IA variations, 390 type IB variations, 72 type II variations and 127 renewals were during June and August No Type II variation, no variation worksharing, or renewal procedure was referred to the in this period. No procedure was referred to the CHMP in this period. The status as of 31 st August 2015 of variations and renewals under Mutual Recognition is as follows: Year Type IA variations Type IB variations Type II variations Variation work-sharing 5 Renewals Referred to Agreement reached in the Withdrawn during referral Applications referred to CHMP referred to in Type II Worksharing Renewal Information on the above mentioned issues can be obtained from the chair of the or from the Secretariat: Dr. Peter Bachmann Phone: Bundesinstitut für Arzneimittel und Fax: Medizinprodukte (BfArM) Kurt-Georg-Kiesinger-Allee 3 D Bonn, Federal Republic of Germany Secretariat Or you could visit the website at: Finalised work sharing do not include work sharing involving centrally approved products coordinated by EMA Page 7/7

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